The present invention relates generally to the field of self-validating documents in supply chain management, documentation services, method and data processing system for creating the same.
Millions of documents are passed in global commerce between supplier and recipient containing control statements within certification documents, such as for the safe use and handling of a product or its compliance with applicable restrictions. Studies have shown a high rate of error in such documents.
Global trade in products between a supplier and a customer depends upon the control statements made in certification documents, such as Material Safety Data Sheets and Safety Data Sheets (MSDS or SDS), letters of certification or compliance certifications, because such control statements define the parameters of use of the product. For example, an MSDS for a hazardous substance or formulation, has become the common means by which the supplier communicates to the customer the controls necessary for safe handling of the product as well as its compliance with applicable restrictions whether in the U.S. at the federal or state level, or the requirements of another country or international convention.
With regard to other types of products, a letter of certification or compliance certification document from the supplier of food and consumer products contains control statements that communicate requirements applicable to the use of the product. For instance, a certification document might accompany the supplier's shipment of a food packaging material to stipulate that the product could be used only with certain types of foodstuffs under the requirements of the Food and Drug Administration or similar governmental agencies of other countries. Such certifications may relate to regulations, standards, religious codes (e.g., keeping Kosher), scientific studies and the like. Millions of such documents are generated and transmitted every year in many different languages and countries for many different types of products and uses.
In many cases such documents are a compilation of standard control statements defining various parameters of use of the product. It is common for such documents to be prepared and generated using a document authoring system or enterprise resource planning (ERP) system such as SAP from a phrase library that may have different language variants.
However, although the recipient of a generated certification document has the control statements for the product, he is not able to obtain or validate the source document supporting a control statement in an automatic way. Nor can the recipient automatically determine whether a change relevant to a control statement in the received certification document might have occurred from the time of the document's creation.
Moreover, the recipient may wish to use the product in a different market or area of the world, and is unable to relate the control statements relevant in one jurisdiction to parameters of use in other jurisdictions or areas. Independently of the supplier's certifications the recipient may also simply wish to review the control statements in a certification document to determine whether information is missing or for which he requires additional information by reviewing the source document of such a statement. Finally, the recipient may wish to relate the general information conveyed about the product in the received document to information about a specific shipment of that product received from the supplier where the shipment has, for example, a particular RFID code. This last aspect is especially important where a product recall or alert has occurred for specific shipments of a product.
It is desirable, therefore, to provide a data processing system to support the automatic validation of control statements made about products flowing through the supply chain. Normally, validation of a control statement is done as a manual task by the recipient. Providing a data processing system for such information will improve the safety of products in the supply chain, will improve the transparency of global product requirements, will reduce cost of product approval, and will reduce mistakes.
It is also desirable for the customer to validate the control statements of the supplier whenever possible through an automatic data processing system. Although the customer must legally rely on the statements of the supplier, a prudent customer may wish to independently validate such a certification by looking up the reference to determine that it is current or to assure himself or herself that important omissions have not been made.
The communication of control statements is not simply a one-to-one relationship between a supplier and a customer, but rather between a many-to-one relationship of multiple upstream suppliers in a supply chain with the customer. The customer may receive a certification document with control statements that depend upon the specific claims of an upstream manufacturer of raw materials used by the immediate supplier of the customer; however, the upstream manufacturer may be unwilling to disclose important source information to the immediate supplier without a non-disclosure agreement, because of claims of confidentiality or trade secrecy.
For example, a manufacturer of a plastic sells to a small converter that produces formed cups to a yogurt food processor. The small converter may provide certifications, but these depend on the materials used in the conversion process. Often it is not the certification statement itself that is confidential; rather it is the source document supporting the statement that is confidential (e.g., test results or toxicological study). Thus, the yogurt food processor has a critical need to be assured of claims or compliance certifications that include both the immediate supplier and the upstream raw material suppliers. The need of the customer is to validate control statements of the immediate supplier as well as—to the extent permitted by the upstream supplier and under terms agreed to by the customer—the control statements passed through the supply chain from upstream manufacturers that concern raw materials or other conditions important to the immediate customer's use of the received product.
Many such certification documents transmitted by suppliers to customers—important though they are—contain omissions or errors. Indeed, according to a recent study of the completeness of safety data sheets: “The deficiencies for the different headings [that is, of the 16 sections of a standard format MSDS] vary between twenty percent and forty percent”. ECLIPS: “European Classification and Labeling Inspections of Preparations, including for Safety Data Sheets”, Final Report 2004 published by the European Enforcement Network, page 11. In consequence, the control statements made in the safety data sheets reviewed in the study have deficiencies that may include missing control statements, out-of-date control statements, or other errors. Further, according to the report, the error rates of regulatory statements in section fifteen of the MSDS, where required regulatory certification statements are made, averaged 35%. Ibid. Similar findings have resulted from Canadian studies. Welsh M. S.; Lamesse M.; Karpinski E. “The Verification of Hazardous Ingredients Disclosures in Selected Material Safety Data Sheets.” Applied Occupational and Environmental Hygiene, Volume 15, Number 5, 1 May 2000, pp. 409-420(12). OSHA has performed studies of MSDS quality:                Based on the chemical ingredients identified, the accuracy in the other four areas of concern was evaluated based on information obtained from readily available reference sources. The evaluation indicated that 37% of the MSDSs examined accurately identified health effects data, 76% provided complete and correct first aid procedures, 47% accurately identified proper personal protective equipment, and 47% correctly noted all relevant occupational exposure limits. Only 11% of the MSDSs were accurate in all four information areas, but more (51%) were judged accurate, or considered to include both accurate and partially accurate information, than were judged inaccurate (10%). (Found at the world wide web address osha.gov/dsg/hazcom/finalmsdsreport.html).        
Given the importance of such certification documents and the control statements that they contain to the safety of the recipient, means to improve accuracy, as addressed in the present invention should be established. A number of studies agree: Error rates in supplier certification statements are high.
In the area of food safety, FDA has established processes for review of hazards: Hazard Analysis and Critical Control Point (HACCP). Nevertheless frequent reports appear where a food processor has purchased a material that contains a contaminant not reviewed adequately.
The probability of error between supplier and customer increases with the volume of certification documents and the number of suppliers. In chemical-using industries, the number of raw materials for a single manufacturer can be thousands or tens of thousands and the number of suppliers in the hundreds or thousands. The same holds true in the food-processing and food-related industries. As a result there is an essential need to improve methods of validation of supplier's statements and to monitor important changes that may have occurred that relate to the supplier's statements.
It is true that the supplier may have proprietary evidence to support a certification and may not have revealed the full composition of a formulation under restrictions on the disclosure of confidential business information, in which case an independent evaluation is limited. Nevertheless, the customer can perform many checks based on the information presented by the supplier, and may as a standard practice adopt a review and validation of a supplier's certification statements.
Further, apart from any regulatory requirements, a number of industries have established their own internal standards that must be met in any procurement of raw materials by the company. For example, Volvo has established: VOLVO Corporate Standard STD 1009,11 (Established February 1998) CHEMICAL SUBSTANCES WHOSE USE WITHIN THE VOLVO GROUP SHALL BE LIMITED (VOLVO'S GREY LIST).
Such ad hoc customer procurement standards that are in addition to any mandatory governmental requirement and accepted only in the face of market pressure have become widely accepted in part because of the difficulties and high error rates in certification documents being passed in the supply chain between supplier and customer. In addition, these standards are subject to change without notice. Such ad hoc standards increase the cost of compliance and its complexity, and reflect the need for an improved method of producing, distributing, and validating certification documents in the supply chain.
A customer has several validation needs:                Accuracy and Currency. Has the supplier correctly cited a supporting reference related to the safe handling of a product and is it current?        Access to Source Documents. Can the customer obtain the cited reference?        Access to Cited References. How can the customer obtain a cited sub-reference within the cited document?        Completeness. Are there other related restrictions or references that have been omitted or overlooked?        Global Scope. Are there similar restrictions in other countries or languages?        Customer's Use vs. Supplier's Scope. Are there other restrictions that apply to the customer's use in another market, but which the supplier has not directly addressed in the certification that are nonetheless critical to the customer (e.g., the customer purchases a product in the U.S., and receives a U.S. certification document but intends to use it as a component or trans-ship it to another country)?        Change Management Regarding Supplier Statements. After a period of time subsequent to the first receipt of the certification how can the customer be informed if an important amendment or modification has occurred related to a certification for the product that the customer has purchased? Again, although many regulations require the automated updating of MSDS or other certifications in the event of a “significant” regulatory change, many recipients seek to independently review supplier information.        Change Management with Regard to Customer's Uses. After a period of time subsequent to the first receipt of the certification how can the customer be informed of other related changes of interest but not provided by the supplier that may affect the customer's use of the product, for example, in a country to which transshipment occurs?        Upstream Supplier Certifications. Access to upstream supplier certifications relating to the immediate supplier's product or changes in these certifications under authorized terms and conditions acceptable to the upstream supplier.        
Today, suppliers and customers seek to establish checks within their business processes and to establish review systems within their organizations, but it is prone to error and oversight especially in light of the complexity of global markets. The reason is straightforward: These review systems are separated from the certification document itself. The present invention provides a data processing system to support automatic validation and addresses this need.
There are many ways in which suppliers generate such certification documents either manually or by automated means within a system. For example, enterprise resource planning systems (ERP's) such as that of SAP (e.g., SAP EH&S) assist suppliers in automatically generating MSDS.
The components of such systems often include:                A composition database containing products and detailed composition and raw materials        Properties tables or databases containing associated values, classifications, and restrictions applicable to substances and properties. Such property tables may also include the automated calculations from business rules;        Phrase libraries—sometimes with translations of phrases—that contain control statements to be included in generated documents;        Transaction control tables that include data that prevents or alerts the potential shipment, purchase, import, export, or sale of a product that may be forbidden;        Document databases that include the generated documents or other documents that may be associated with a product, substance, or process; and,        Business rule tables with conclusions (Left Hand Side—LHS) actions that depend on criteria (Right Hand Side—RHS parameters). For example, if benzene is a component in a formulation greater than 0.1 percent used in the United States, then insert the phrase code associated with the conclusion “carcinogenic” into the properties table for this substance identifier.        
There are a number of current limitations in such systems:                ERP and document authoring systems as SAP EH&S, do not today include a dynamic component, such as a hyperlink, in phrase libraries of control statements used in the creation of certification documents, one that permits the recipient to validate a control statement within a received document in an automatic manner;        ERP and document authoring systems do not provide for validation of control statements through automatic means in generated certification documents for products from within the generated documents;        Although it is common for a manufacturer to hyperlink from a product listing on a web-site page to a related MSDS or technical document associated with the product, for example, it does not exist that the control statements in the certification document hyperlink to the authoritative source document for that statement or data element.        Data processing systems do not exist to pass certification documents containing dynamic control statements with hyperlinks in business-to-business exchange of such between computer systems in computer readable form so that the control statements with hyperlinks can be extracted and placed in a database for further use.        As a result, such data processing systems do not today allow the generation of certification documents that permit automated third-party validation and change management support services in association with control statements made.        Such data processing systems do not use the loading and storage of certification documents with control statements using hyperlinks.        It is not possible to obtain direct access to upstream manufacturer control statements or certification documents as described through a central service and no general practice or data processing system exists to provide this information.        
One of the most difficult tasks of regulatory managers within supplier and customer organizations is keeping up with new or modified regulations or standards. Such compliance tracking tasks focus on the raw materials purchased, the substances manufactured, the processes themselves, or the products sold or distributed. The regulatory manager may use enterprise systems, subscribe to publications, participate in trade organizations, or search the web for information about change.
Equally difficult is the task of determining or obtaining upstream raw material certifications for products obtained from the immediate supplier.
It is desirable, therefore, to provide the capability for such a regulatory manager to validate a dynamic control statement within a certification document by a hyperlink to the source document supporting the control statement. In addition, it is desirable to provide the capability for the recipient of a certification document to determine by clicking a hyperlink whether amendments, new requirements, or modifications that pertain to a control statement have occurred for a given period of time, for example, since the time that the certification document was generated.
It is desirable, therefore, to provide a system by which a recipient's computer system can receive a certification document with its control statement from an upstream supply chain actors in such a manner that the recipient can store and re-use these control statements in authoring a further certification document for a product where the parameters of use are dependent on the control statements of the upstream supplier. Further, the downstream recipient does not have a system by which he can validate the control statements of the upstream provider, if authorized.
There are many services where you can enroll to receive updates of journals, regulations with customized scope defined by the user. Such services include:                Westclip on Westlaw        ECLIPSE on Lexis/Nexis        U.S. Federal Register        
However, the regulatory manager, researcher, or document recipient is interested in changes that relate to the context of the certification document and a particular control statement within it, which at present means that the process of analyzing the control statements within a certification document is separate from and totally independent of the process of tracking changes. The complexity and discontinuity of these two important processes—receiving the certification document and determining changes that relate to such a document's control statements—increase the probability of accidental non-compliance.
In addition to the data processing system for self-validation of certification documents, it is desirable for the researcher to obtain relevant documents from a searching or indexing system that will return a compilation of documents that includes not only direct references to the search term for a material but also a synonym, identifier, translation, or reference to a class or group containing the search term as a member. It is also desirable if the document reference from such a search will return the document opened at the relevant page with the applicable direct reference, synonym, identifier, translation, or reference to a class or group containing the search term as a member. Finally, it is desirable if the researcher can obtain a subset of documents, for example, only those that have changed where the returned reference is to a document containing not only a direct reference, but also a synonym, identifier, translation, or reference to a class or group containing the search term as a member.
Publishers maintain large libraries of abstracts of knowledge in various areas related to science and business, among other fields. One example is the ILLUMINA® system published by CSA and another is SCOPUS® by Reed-Elsevier. Although such systems may contain links to the full-text documents associated with an abstract, they do not include either the search capabilities or validation system as described in this invention.
Referring now to FIG. 12, an example prior art search from Google® illustrates the need. In this instance, the researcher has searched for a material, specifically, a chemical, which is “crotonic acid”. Google® returns two thousand five hundred and twenty (2,520) document references. Entering a synonym, “(E)-2-Butenoic acid” returns only twenty-two (22) document references. A Dutch synonym, “Crotonzuur” returns no hits and the message: “Try different keywords”. This search illustrates both a searching display and a searching index that does not return document references that include a compilation of not only direct references, but also synonyms or translations of a material term. This is a common approach of existing search displays and indexing methods, for example, Google®, SCOPUS®, ILLUMINA®, and others.
In searching for documents relevant to a material, the research is often interested in documents that include a reference to a class of which the search term is a member. For example, if the user enters the term, “crotonic acid”, he or she may be interested in a document that refers to “Ungesättigte aliphatische Mono- und Dicarbonsäuren” because the meaning of this chemical class with many members includes the specific substance, crotonic acid. Similarly, if the user searches for “sodium chromate”, the user would be interested in documents that include a reference to “hexavalent chromium compounds”. Such indirect references to broad classes including the direct search term are not returned by the example searches above of Google®.
The search term and interest in a reference to a broad group may not necessarily be a chemical, but also a foodstuff, biologic, or formulation. A comprehensive search for the term, “orange”, according to the present invention, should return a link to a document including a reference to “citrus fruits, except lemon and limes”. Current search systems may return synonyms, (e.g., TOXNET) and may include related identifiers and translations of substance names, but do not include a systematic cross-referencing system for such; nor do they include parent classes within the context of the regulation or referenced document.
An identifier for a material is a particular type of synonym. Many such identification systems are used by regulatory or scientific organizations, where an alphanumeric code represents a material. For example, the European Union uses EINECS numbers to refer to existing chemicals. FDA has its own system, as do the governments of Japan and Korea. Other systems, include color index numbers, etc. It is desirable to provide a system and method that spans any identifier returning documents that include a reference, whether that reference is a synonym, translation, parent group or class, or identifier in addition to any direct reference.
Web-based search engines do not include such features whether in the simultaneous display of document links containing references to synonyms, translations, identifiers, and parent groups in addition to direct references or whether in methods used to index documents to extract references to such terms.
Current systems, including those noted above, do not:
                Search with the scope and methods described above or in this invention; nor        Return a document opened at the relevant page with the term highlighted.        